FDA approves a Merck BLA for Winrevair (sotatercept-csrk) for injection for treating adults with pulmonary arterial hypertension.
Federal Register proposed rule: FDA proposes to ban electrical stimulation devices intended for self-injurious behavior or aggressive behavior.
Federal Register notice: FDA makes available a guidance entitled Handling and Retention of BA and BE Testing Samples.
FDA warns Chinas Deqing Jiarou Daily Chemical Co. about CGMP violations in its production of finished drugs.
FDA warns Bend, OR-based ReNovo that its reprocessed single-use medical devices are adulterated and misbranded and have Quality System violations.
Rep. Earl Blumenauer asks FDA to explain why it approved human trials for Elon Musks Neuralink medical device before inspecting its facility.
Two CDER Office of Clinical Pharmacology doctors use a podcast to explain a new guidance on considerations for antibody-drug conjugates.
The majority of U.S. Supreme Court justices appear skeptical during oral arguments on whether there should be a ban or any new restrictions on the abo...
